The present invention relates to a low profile instrument for introducing and rotating a prosthetic heart valve during implantation.
Holders for positioning heart valve prosthesis are used for positioning (i.e., holding, supporting and rotating) prosthetic heart valves during surgery. Often heart valve replacement surgery includes a median sternotomy or a large left thoracotomy to gain unobstructed access into a patient's thoratic cavity. Such procedures allow the surgeon to see the patient's heart more directly, and to have more direct instrument access for: (1) excising the natural valve tissue; (2) introducing a heart valve prosthesis into the patient's natural valve annulus; (3) securing the prosthetic valve into position; and (4) rotating the orifice and leaflet assembly of the prosthesis to minimize interference with the heart's subannular anatomy. However, these invasive, open-chest procedures produce a high degree of trauma, a significant risk of complications, extended hospital stay, and a painful recovery period for the patient.
Recently, less invasive cardiac surgery techniques have been developed where an open-heart surgery is performed through small incisions between two ribs. This small intercostal thoracotomy is performed instead of a median sternotomy or other form of gross thoracotomy, substantially reducing the above-mentioned trauma, risk of complication, recovery time, or pain for the patient. However, when performing this procedure, care must be taken not to spread the ribs too far. Some surgeons have recently indicated that a thoracotomy incision should not be spread greater than 15 millimeters for an intercostal insertion since deflecting the ribs to a greater dimension can result in significant pain for the patient. The nerve under the rib can be crushed and damaged if the intercostal incision is spread beyond the 15 millimeters.
Therefore, the devices and instruments for performing percutaneous penetrations within these intercostal spaces for less-invasive heart or great vessel surgery must be simple and have "low profile". Currently marketed rotators and valve holders are too bulky to fit through this intercostal space without spreading the patient's ribs too far, and are more complicated than necessary to simply and reliably percutaneously introduce and rotate a prosthetic valve during implantation.